Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

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Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks ]

Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:

1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes.

A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:

Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results [ Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks ]

Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:

1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal.

Percentage of Participants Who Developed Antibodies to ABP 501 [ Time Frame: Up to week 72 ]

Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.

Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study.

Secondary Outcome Measures :

Percentage of Participants With an American College of Rheumatology (ACR) 20 Response [ Time Frame: Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70 ]

A participant was a responder if the following 3 criteria for improvement from Baseline of the parent study were met:

The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:

The number of swollen and tender joints assessed using the 28-joint count;

C-reactive protein (CRP) level

Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).

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Ages Eligible for Study:

18 Years to 81 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit

Exclusion Criteria:

Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental

Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262

Current infection requiring the use of oral or intravenous antibiotics